FDA MedWatch Warning 6/4/08

[Maz]

Further the latest RBF E-Bulletin, wherein it was noted that Enbrel had just been approved for children with JRA over 4, this warning now comes predictably in on its heels:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#TNF

Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia)

Audience: Rheumatologists, gastroenterologists, oncologists, other healthcare professionals
[Posted 06/03/2008] FDA issued an Early Communication About an Ongoing Safety Review to inform healthcare professionals that the Agency is investigating a possible association between the use of Tumor Necrosis Factor (TNF) blockers and the development of lymphoma and other cancers in children and young adults. FDA is investigating approximately 30 reports of cancer in children and young adults. These reports were submitted to FDA's Adverse Event Reporting System over a ten-year interval, beginning in 1998 through April 29, 2008. These reports describe cancer occurring in children and young adults who began taking TNF blockers (along with other immuno-suppressive medicines such as methotrexate, azathioprine or 6-mercaptopurine), when they were ages 18 or less, to treat juvenile idiopathic arthritis, Crohn's disease or other diseases. Approximately half of the cancers were lymphomas, including both Hodgkin's and non-Hodgkin's lymphoma. Long-term studies are necessary to provide definitive answers about whether TNF blockers increase the occurrence of cancers in children because cancers may take a long time to develop and may not be detected in short-term studies. Until the evaluation is completed, healthcare providers, parents, and caregivers should be aware of the possible risk of lymphoma and other cancers in children and young adults when deciding how to best treat these patients.

[June 04, 2008 – Early Communication About an Ongoing Safety Review of TNF Blockers – FDA]
Thanks to Carolyn on CT Lyme for sharing this important information. 😀

Peace, Maz

[Suzanne]

“Until the evaluation is completed, healthcare providers, parents, and caregivers should be aware of the possible risk of lymphoma and other cancers in children and young adults when deciding how to best treat these patients.”

I'm glad to see the FDA is giving a 'shout out' to parents on this one.  I'll have to see if that usually happens when they post a warning.

It mentions 30 cases and four biologics.  I would love to know how the cancers were spread out among the different meds.  Also, the most children would have been on Enbrel, then probably Humira next.  I would like to know if Remicade had a disproportionate numbers of cancers, for example.

The risk of cancer has been low on my list of worries until now.

Mom of teen daughter with Poly JIA since age 2. Current med: azithromycin 250 mg MWF.

[Maz]

Hi Suzanne…yes, will indeed be interesting to see how this unfolds with time. Last year, apparently 375 people died from complications due to Enbrel, according to Dr S on the chat the other night.

Peace, Maz

[Suzanne]

[user=18]Suzanne[/user] wrote:

“.

It mentions 30 cases and four biologics.  I would love to know how the cancers were spread out among the different meds. 

I'm quoting myself, because I realized this was a dumb thing to say LOL. 
I don't think they could know which biologic caused the cancer if the kids took more than one, right?  From what I read, until last year or so, most kids started on Enbrel, if it failed went to Humira, then Remicade was last.   I did see a couple posts last year about very young kids going straight to Remicade after mtx (I guess their ped rheums had already given up on the other two???)

If you thought you were cancer-free on Enbrel, and got sick just as you started Humira, what would make of that?  I'm thinking they just won't pin the blame on any one of those meds.

Mom of teen daughter with Poly JIA since age 2. Current med: azithromycin 250 mg MWF.

[Suzanne]

[user=27]Maz[/user] wrote:

Hi Suzanne…yes, will indeed be interesting to see how this unfolds with time. Last year, apparently 375 people died from complications due to Enbrel, according to Dr S on the chat the other night.

Peace, Maz

Maz,

I've seen that and another statistic mentioned from the chat.  I'd love to see the source of his statements about Enbrel.  I'd like to share those numbers, but need more than 'a doctor said it in a chatroom' LOL.

Mom of teen daughter with Poly JIA since age 2. Current med: azithromycin 250 mg MWF.

[Maz]

Hi Suzanne,

I see your very important points on both counts…both how to pin down which biologic may have caused cancers and where Dr S got his stats. I can't give you any answers on either, but my personal feeling about this is that any child (or adult) that is put at risk (no matter how small the risk) of a life-threatening disease from a drug is a concern that should be brought into public awareness. Fortunately, the FDA is doing the right thing by expressing this concern. The unfortunate side of this is that forewarned patients, or parents of patients, really have no comeback if they choose a biologic and this sadly occurs.

I'm not sure how many deaths or serious consequences need to occur before a drug is withdrawn from the market, do you? There was that whole rucous about Celebrex a few years ago and this drug is still on the market and being widely used, with the usual pharmaceutical disclaimers, of course.

That said, many patients do find relief from drugs that have potentially dangerous side-effects and still choose to take them, because they feel they have no alternative… rheumatological DMARDs being amongst some of the most toxic on the market. That's why the Road Back Foundation is being kept alive…to alert patients to a safe, proven alternative. 😀

Peace, Maz

[Suzanne]

[user=27]Maz[/user] wrote:

I'm not sure how many deaths or serious consequences need to occur before a drug is withdrawn from the market, do you? There was that whole rucous about Celebrex a few years ago and this drug is still on the market and being widely used, with the usual pharmaceutical disclaimers, of course.

That said, many patients do find relief from drugs that have potentially dangerous side-effects and still choose to take them, because they feel they have no alternative… rheumatological DMARDs being amongst some of the most toxic on the market. That's why the Road Back Foundation is being kept alive…to alert patients to a safe, proven alternative. 😀

Peace, Maz

I hope physicians and patients do not move up to stronger drugs with so many unknowns unless they truly feel there is no other choice.  Our ped rheum believes “early aggressive” has the best outcome and currently is recommending Humira, mtx, NSAID, Prevacid, and sedation for a steroid injection.  Sigh.

Well, we've passed the “early” part by now, anyway.  But look what has changed while she has been on AP…..

He used to say Enbrel, Enbrel, Enbrel.  When I asked about Humira, he even called another ped rheum and made this huge big deal to say they were the same.  Then, in Oct., it was Enbrel AND Humira (which, according the most recent ACR Recommendations is not recommended for ANYONE due to the risk of serious adverse events and lack of additive efficacy, let alone 4 yr. old little girls who dance around the exam room). 

In March, we got the latest set of his recommendations.  Enbrel is nowhere to be found.  He says Humira is being shown to work better now.  So we got to the skip that one without actually having to subject her to it.  Cool. 

But we never say never, and if some day my daughter needs more than AP to have a good quality of life, we will have to make a hard decision.  If she was suffering, it probably wouldn't be hard to take the risk.  But for now, there is no benefit that would outweigh the risk.

Mom of teen daughter with Poly JIA since age 2. Current med: azithromycin 250 mg MWF.

[Maz]

[user=18]Suzanne[/user] wrote:

But we never say never, and if some day my daughter needs more than AP to have a good quality of life, we will have to make a hard decision.  If she was suffering, it probably wouldn't be hard to take the risk.  But for now, there is no benefit that would outweigh the risk.

Yes, completely understand your dilemma….it's pretty much what we each have to face when making an informed treatment decision, although I'm sure if any of us had small whippernappers in the same boat, we'd be just as ambivalent, and willing to do whatever it took to get them out of pain. Will just put it out there with you that it won't ever come to this and she'll just keep on getting better and better with time. I do hope so. She's so lucky you're her Mom!

Peace, Maz

[barneka]

Hello,

I am new to this site. I noticed you were online andwas wondering if you could help me with my 22 mth old daughter? She has seen a rheum. and we have been told she possibly has Systemic Juv. Rheum Arthritis or something called TRAPS. Are you familiar with anyone who has used the antibiotic therapy for Systemic JRA? Any help would be greatly aprreciated.

Kim and Brooke(22mths)

 

[Maz]

Hi Kim,

Am I right in thinking that systemic JRA is the same as Still's Disease? Suzanne is our JRA parent expert here and should be able to offer some excellent insights to you.

As far as I know, however, Dr Brown was successful in treating a number of children with JRA.

If you would like a listing of antibiotic protocol physicians in your city/state, just let me know where you're located and I'd be happy to send you a list. Not all docs will treat pediatric cases, so you may have to do some legwork (Suzanne may be able to help you here), but it should be worth your while. Normally, the tetracyclines aren't used in young children due to tooth discoloration, but there are alternative antibiotics used, including liquid suspension azithromycin.

So sorry to hear your little one has been afflicted with this rotten disease and that you had to find yourself here…but you've found a very good place where there is much hope. Keep the faith…antibiotic protocol (AP) has worked for many, many people and there is a very good chance it will work for your little one, too. It is, by far, much safer than the other toxic meds normally used.

Peace, Maz

[barneka]

Yes, I  am from Texas but am willing to travel anywhere to help my daughter. Please send me a list of doctors so I may get started. Thanks

[Maz]

Hi Kim,

I'll put that together for you now and send to you in a private message in a few mins. Just go to top of the page on right and you will see “1 new message” when it arrives in your inbox. Click there to retrieve it.

It's after midnight here in CT, so I will be signing off for the night. Hopefully, Suzanne will be checking in soon and she may be able to provide some very good insights for you on physicians that have been able to help her with her young one.

All the very best in your searches for the best AP doc for your precious baby.

Peace, Maz

[Susan LymeRA]

Just want to take a moment to stress to parents and young adults, if you or your child has taken/is taking these drugs, be sure they go on a very good, anti-cancer diet.  Sugar feeds cancer cells. 

There is much knowledge and agreement out there concerning the best anti-cancer diets.  It will always be centered around fresh vegetables and some fruits.  The right vegetables are the cruciferous ones: brocolli, brussel sprouts, cabbage, cauliflower, onions, garlic, etc.  But a good variety of all vegetables and a few, low sugar fruits will go a long,  A LONG, way toward preventing and even curing cancer.

I'm betting children and young adults are more suspectable to these cancers because they are the least likely to be eating healthily.    I have a very good report on Cancer from Dr. Blaylock that tells you more what to do to reduce your chances of cancer and increase your chances of recovery but no time now to report.  I will come back later with more information.

Susan

 

 

[Joe M]

Hi Suzanne,
I too wish they would be more specific with their data.  From what I could find, there are between 300,000 and 400,000 prescriptions for Enbrel for children in the United States every year.  They have 30 reported cases of cancer over 10 years – 3 per year.  Of these three per year, how many had undetected cancer before starting the TNF blocker?  It's good of the FDA to be safe rather than sorry, but they need to be careful about how they report the numbers so people can keep the proper perspective when making the difficult decision to start one of these meds.

[Jo]

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